Omentectomy vs Omental Preservation in Resectable Cancer
Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
1 other identifier
interventional
569
0 countries
N/A
Brief Summary
European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2). Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed. The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
February 28, 2023
February 1, 2023
2.5 years
February 7, 2023
February 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
disease free interval
time between surgery and recurrence. Units of measure: months
5 years
Secondary Outcomes (4)
global survival
5 years
survival at 5 years
5 years
complications - CCI
30 days after surgery
postoperatory mortality
30 days after surgery
Study Arms (2)
Omentectomy
OTHEROmentectomy during cancer gastric surgery
Omental preservation
OTHERPreserval omentation during cancer gastric surgery
Interventions
Omentectomy vs omental preservations during gastric surgery
Eligibility Criteria
You may qualify if:
- Older than 18 years old
- Resectable gastric cancer
- Gastric cancer T3-4 N+/- M0
You may not qualify if:
- Non surgical patients for medical status
- Non resectable gastric cancer during surgery
- Endoscopic resectable gastric cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 28, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2031
Last Updated
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share